Editorial statement on the nomenclature for refractive lenticule extraction procedure

The editors of the Journal of Cataract & Refractive Surgery published a joint editorial statement on the scientific nomenclature for keratorefractive lenticule extraction (KLEx) procedures. In the piece, they described the evolution of terminology for the procedure by which a lenticule is created by femtosecond laser and extracted for correction of refractive error, from early terminology in the scientific literature to branded, proprietary terminology currently in use. They wrote, “a proliferation of new proprietary terms aimed at market differentiation can … create confusion and obscure the common mechanistic underpinnings of these procedures.” As such, the authors of the editorial deliberated on creating a term that would have descriptive accuracy, sufficient specificity, sufficient breadth, and avoid proprietary names. They settled on “keratorefractive lenticule extraction (KLEx),” pronounced “kay-lex.”

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First patient dosed in Phase 1/2 trial evaluating allogenic cell therapy for corneal edema

Aurion Biotech announced that the first patient has been dosed as part of its Phase 1/2 clinical trial of AURN001, an allogenic cell therapy, for the treatment of corneal edema secondary to corneal endothelial dysfunction. According to the company’s press release, AURN001 is a biologic-drug combination of “neltependocel (allogeneic human corneal endothelial cells [CECs]) and Y-27632 (an inhibitor of Rho-associated, coiled-coil containing protein kinase [ROCK]).” It is delivered via intracameral injection. The Phase 1/2 study is prospective, multicenter, randomized, double-masked, and parallel-arm cell dose-ranging, evaluating three different doses with the primary endpoint being percentage of patients who gain three lines of vision at 6 months post-injection. The study will randomize about 100 participants.

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IND granted to company investigating therapy for geographic atrophy

Endogena Therapeutics announced that the FDA cleared its Investigational New Drug application for EA 2351, an investigational therapy for geographic atrophy, allowing the compound to undergo clinical trials. According to the company’s press release, EA 2351 targets retinal pigment epithelial cells, which the company stated, play a role in photoreceptor regeneration and restoration.

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Licensing agreement to develop neuroprotective drug

Stuart Therapeutics announced that it entered into a license agreement with Glaukos to develop and commercialize a drug candidate for neuroprotection in patients with glaucoma. The drug is ST-113, which in pre-clinical animal models has demonstrated neuroprotective and neuro-repair of optic nerve axons. ST-113 is described as a “a synthesized collagen mimetic peptide, which selectively restores damaged helical collagen in the extracellular matrix.” It is “believed to restore both the structural and cell signaling roles of collagen in the optic nerve region, reducing inflammation, and restoring nerve health.”

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Retinal imaging test detects increased risk for type of dementia

There is a growing body of research linking several ocular tests and tools with detection capabilities for brain-based diseases such as dementia. The University of Southern California Keck School of Medicine reported research that showed OCT-angiography (OCT-A) could be a “possible tool for screening Black Americans and others from underdiagnosed and high-risk populations for cerebral small vessel disease.” According to the university’s news article about the research, this disease is a contributor to cognitive impairment and dementia, with vascular dementia being the second most common dementia diagnosis after Alzheimer’s. A researcher in the article stated that most diagnoses of cerebral small vessel disease do not occur until there is significant, irreversible brain damage. Non-invasive OCT-A could detect risk and disease at a much earlier stage when treatment would be beneficial. The study was conducted with data from the African American Eye Disease Study, which included more than 6,000 African American participants; those in this study were more than 40 years old and had no history of cognitive impairment. OCT-A tests were able to show changes in retinal capillaries prior to development of clinical symptoms. The university described “certain early structural changes in the brain [… being] known biomarkers of cerebral small vessel disease.” The research is published in the journal Alzheimer’s & Dementia.

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ASCRS news and events

• A Taste of ASCRS: This nine-section CME program is available on demand. Learn more about the program.
• ASCRS Podcast: Episode 4 of Season 3 in Ophthalmology Quicksand Chronicles—Eureka Moments! is online now.
• ASCRS Annual Meeting: There is an open call for submissions for case videos for four sessions at the 2024 ASCRS Annual Meeting. Click here to learn more about each of these opportunities and how to submit.

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Research highlights

• The impact of corrected refractive power on corneal denervation with SMILE and LASIK were evaluated in a prospective study published in the Journal of Cataract & Refractive Surgery. Eighty-eight eyes that had SMILE or LASIK were divided into a low-moderate correction group (MRSE was less than –6 D) and a high myopic correction group (MRSE was –6 D or more). After the procedure, in vivo confocal microscopy and clinical assessments were performed. The authors found that postop corneal denervation was related to corrected refractive power in both procedures. However, they wrote, “LASIK led to more prominent corneal denervation” when the same refractive correction was conducted, compared to SMILE.
• The safety and efficacy of topical vitamin D use in the management of dry eye associated with meibomian gland dysfunction (MGD) was the subject of a placebo-controlled, double-blind, randomized controlled trial published in the journal Cornea. The study enrolled a group of 28 patients (28 eyes) who received either vitamin D or placebo in their randomized eyes. According to the paper, there was improvement in subjective parameters in both groups, but a statistically significant greater improvement was seen in the vitamin D group in OSDI scores and DEQ5 scores at 8 weeks. The authors also reported a significant difference between the treatment and control groups in Schirmer testing, tear breakup times, corneal fluorescein staining, and meibomian gland expressibility scores. With that, the authors concluded that these preliminary results “suggested that use of topical vitamin D drops with a lipid vehicle could be safe and might significantly improve the symptoms and signs of dry eye associated with MGD.”

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Product news

• Bausch + Lomb launched Eyetelligence, a new surgical planning software that integrates with electronic medical record systems and diagnostic devices, as well as the company’s Stellaris Elite Vision Enhancement System.
• Harrow completed the transfer of New Drug Applications for the following, launching these products, which it acquired commercial rights to earlier this year, under the Harrow name: Flarex (fluorometholone acetate ophthalmic suspension) 0.1%, Natacyn (natamycin ophthalmic suspension) 5%, Tobradex ST (tobramycin and dexamethasone ophthalmic suspension) 0.3%/0.05%, Verkazia (cyclosporine ophthalmic emulsion) 0.1%, and Zerviate (cetirizine ophthalmic solution) 0.24%.

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